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Computed tomographic colonography compared with colonoscopy or barium enema for diagnosis of colorectal cancer in older symptomatic patients: two multicentre randomised trials with economic evaluation (the SIGGAR trials)

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2015 07 Halligan S et al, NIHR-HTA Final Report (SIGGAR).pdfPublished version4.58 MBAdobe PDFView/Open
Title: Computed tomographic colonography compared with colonoscopy or barium enema for diagnosis of colorectal cancer in older symptomatic patients: two multicentre randomised trials with economic evaluation (the SIGGAR trials)
Authors: Halligan, S
Dadswell, E
Wooldrage, K
Wardle, J
Von Wagner, C
Lilford, R
Yao, GL
Zhu, S
Atkin, W
Item Type: Journal Article
Abstract: Background: Computed tomographic colonography (CTC) is a relatively new diagnostic test that may be superior to existing alternatives to investigate the large bowel. Objectives: To compare the diagnostic efficacy, acceptability, safety and cost-effectiveness of CTC with barium enema (BE) or colonoscopy. Design: Parallel randomised trials: BE compared with CTC and colonoscopy compared with CTC (randomisation 2 : 1, respectively). Setting: A total of 21 NHS hospitals. Participants: Patients aged ≥ 55 years with symptoms suggestive of colorectal cancer (CRC). Interventions: CTC, BE and colonoscopy. Main outcome measures: For the trial of CTC compared with BE, the primary outcome was the detection rate of CRC and large polyps (≥ 10 mm), with the proportion of patients referred for additional colonic investigation as a secondary outcome. For the trial of CTC compared with colonoscopy, the primary outcome was the proportion of patients referred for additional colonic investigation, with the detection rate of CRC and large polyps as a secondary outcome. Secondary outcomes for both trials were miss rates for cancer (via registry data), all-cause mortality, serious adverse events, patient acceptability, extracolonic pathology and cost-effectiveness. Results: A total of 8484 patients were registered and 5384 were randomised and analysed (BE trial: 2527 BE, 1277 CTC; colonoscopy trial: 1047 colonoscopy, 533 CTC). Detection rates in the BE trial were 7.3% (93/1277) for CTC, compared with 5.6% (141/2527) for BE (p = 0.0390). The difference was due to better detection of large polyps by CTC (3.6% vs. 2.2%; p = 0.0098), with no significant difference for cancer (3.7% vs. 3.4%; p = 0.66). Significantly more patients having CTC underwent additional investigation (23.5% vs. 18.3%; p = 0.0003). At the 3-year follow-up, the miss rate for CRC was 6.7% for CTC (three missed cancers) and 14.1% for BE (12 missed cancers). Significantly more patients randomised to CTC than to colonoscopy underwent additional investigation (30% vs. 8.2%; p < 0.0001). There was no significant difference in detection rates for cancer or large polyps (10.7% for CTC vs. 11.4% for colonoscopy; p = 0.69), with no difference when cancers (p = 0.94) and large polyps (p = 0.53) were analysed separately. At the 3-year follow-up, the miss rate for cancer was nil for colonoscopy and 3.4% for CTC (one missed cancer). Adverse events were uncommon for all procedures. In 1042 of 1748 (59.6%) CTC examinations, at least one extracolonic finding was reported, and this proportion increased with age (p < 0.0001). A total of 149 patients (8.5%) were subsequently investigated, and extracolonic neoplasia was diagnosed in 79 patients (4.5%) and malignancy in 29 (1.7%). In the short term, CTC was significantly more acceptable to patients than BE or colonoscopy. Total costs for CTC and colonoscopy were finely balanced, but CTC was associated with higher health-care costs than BE. The cost per large polyp or cancer detected was £4235 (95% confidence interval £395 to £9656). Conclusions: CTC is superior to BE for detection of cancers and large polyps in symptomatic patients. CTC and colonoscopy detect a similar proportion of large polyps and cancers and their costs are also similar. CTC precipitates significantly more additional investigations than either BE or colonoscopy, and evidence-based referral criteria are needed. Further work is recommended to clarify the extent to which patients initially referred for colonoscopy or BE undergo subsequent abdominopelvic imaging, for example by computed tomography, which will have a significant impact on health economic estimates.
Issue Date: 1-Jul-2015
Date of Acceptance: 1-May-2014
URI: http://hdl.handle.net/10044/1/44648
DOI: https://dx.doi.org/10.3310/hta19540
ISSN: 1366-5278
Publisher: NIHR Health Technology Assessment Programme
Start Page: 1
End Page: +
Journal / Book Title: Health Technology Assessment
Volume: 19
Issue: 54
Copyright Statement: © 2015 Queen’s Printer and Controller of HMSO. This work was produced by Halligan et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Sponsor/Funder: Department of Health
Cancer Research UK
Funder's Grant Number: 02/02/01
C8171/A16894
Keywords: Science & Technology
Life Sciences & Biomedicine
Health Care Sciences & Services
INCIDENTAL EXTRACOLONIC FINDINGS
COST-EFFECTIVENESS ANALYSIS
ROW CT COLONOGRAPHY
VIRTUAL COLONOSCOPY
MEDICARE POPULATION
RELATIVE SENSITIVITY
ASYMPTOMATIC ADULTS
CLINICAL-PRACTICE
BOWEL PREPARATION
AORTIC-ANEURYSM
Aged
Aged, 80 and over
Barium Sulfate
Colonography, Computed Tomographic
Colonoscopy
Colorectal Neoplasms
Cost-Benefit Analysis
Early Detection of Cancer
Enema
Female
Humans
Male
Middle Aged
Patient Satisfaction
Sensitivity and Specificity
Sigmoidoscopy
United Kingdom
Great Britain
Health Policy & Services
1117 Public Health And Health Services
0807 Library And Information Studies
0806 Information Systems
Publication Status: Published
Appears in Collections:Division of Surgery
Faculty of Medicine



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